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OMB Control No: 0910-0650	ICR Reference No: 201507-0910-007
Status: Historical Active	Previous ICR Reference No: 201304-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Tobacco Product Establishment Registration and Submission of Certain Health Information
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/07/2016
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/29/2015
Terms of Clearance: This ICR Extension is approved to continue this ongoing collection. However, upon publication of the Tobacco Deeming Final Rule(RIN 0910-AG38) an ICR Revision request will be submitted to adjust the requested burden hours to account for the anticipated increase in applications submitted post effective date of the rule. In addition, the data to be collected by the FDA’s Center for Tobacco Products (OMB Control No. 0910-0650) and Center for Disease Control (OMB Control No.’s: 0920-0210 and 0920-0338) overlap in terms of the similar tobacco product ingredient collections being conducted. However, at this time, the CTP data cannot currently be used by CDC due to both logistical reasons and restrictions on the use of information collected. OMB encourages the agencies to consider future efforts to eliminate duplication and reduce burden on respondents

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2019	36 Months From Approved	01/31/2016
Responses	818	0	408
Time Burden (Hours)	1,084	0	1,092
Cost Burden (Dollars)	2	0	2

Abstract: The Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by the Tobacco Control Act of 2009, grants FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Section 905 of the FD&C Act requires the annual registration of any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products. Section 904 of the FD&C Act requires that each tobacco product manufacturer or importer submit a listing of all ingredients and additives that are added by the manufacturer to each tobacco product by brand and by quantity in each brand and sub brand. Section 904 also requires that a tobacco product manufacturer advise the FDA in writing prior to adding any new tobacco additive or increasing in quantity an existing tobacco additive. It also requires that a tobacco product manufacturer advise the FDA in writing prior to eliminating or decreasing an existing additive, or adding or increasing an additive designated by the FDA as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use.

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	818	408	410
Annual Time Burden (Hours)	1,084	1,092	-8
Annual Cost Burden (Dollars)	2	2	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: After an internal review of this collection's burden hours, FDA realized that the number of respondents had been understated, based on data received from another federal agency, and has been revised from 125 to 135 respondents. The breakdown in information being collected has been split into specific categories under sections 904 and 905 of the Tobacco Control Act from the last approved collection to specifically identify what information under each section is being collected. • The burden for responding to this collection of information has been adjusted to fully incorporate the use of FDA's new electronic system known as FURLS for submitting registration and product listing information to FDA. The FURLS system allows companies to enter information quickly and easily, resulting in a slight decrease in hours through its use when entering Registration and Listing information. FURLS is a relatively new system for FDA and allows companies an easier way to enter, review, and revise previously entered information, and also allows registrants the ability to easily submit electronic labels, ads, and other information more accurately and quickly.

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